The primary objective of the trial is to test safety and to identify the recommended Phase 2 dosing. The secondary objectives are to test tumor marker Kinetics measured in the blood via standard assays; PSA, CA-125, CEA, etc. We added exploratory objectives to monitor the growth of cancer as measuring by cat scan, bone scan, or other imaging modality that was being used to monitor the patient’s cancer.
“We also wanted to explore potential targets, biomarkers, predictors in PBMCs (peripheral blood mononuclear cells), to access tumor burden dynamics through serum and plasma, to evaluate germ-line mutations in circulating DNA, and to see changes in cytokine productions in PBMCs.
Patient eligibility criteria requires that a patient be a solid tumor patient, stage IV, that at least one line of prior systemic therapy or other standard treatment, and have a life expectancy of greater than three months.
A standard 3 + 3 design was used where three patients in the trial are assigned to a dose level in order of the study entry until a subject experiences a drug-related toxicity of a grade two or higher, whereupon an additional three patients will be enrolled at that does level.”
To date Dr. Paller has consented 15 patients into the trial and is expecting 16-22 more! The trial is progressing well and will take another 2 years to complete because the FDA has required us to follow-up with a patient for 28 days after their initial dose.